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WAREHAM, MA, USA – Synomics Pharma and BioScience Laboratories, Inc. recently announced a formal partnership to provide fully integrated topical clinical phase 1 study services for trials in healthy human subjects, providing drug developers with a single source for outsourcing clinical trials. Synomics Pharma’s preclinical and clinical bioanalysis and analytical chemistry services, combined with BioScience Laboratories’ 18 years of experience conducting clinical trials, provides drug developers with a comprehensive outsourcing solution for topical clinical phase I study needs in a GCP and GLP compliant environment.
As the need for improved quality of data from clinical trials rises, drug developers are increasingly turning to United States-based contract research organizations (CROs). To ensure regulatory acceptance, pharmaceutical developers are requiring that clinical trials be conducted in strict compliance with the FDA, GCP, and GLP guidelines. For drug developers trying to bring a product to market while adhering to stringent timelines, selecting a CRO capable of conducting the clinical trial on time, on budget, and with resulting data suitable for FDA submission is critical.
The partnership between Synomics Pharma and BioScience Laboratories enables an efficient single point of project management, with a full array of bioanalytical and topical clinical trial capabilities. “Our significant experience in conducting clinical trials, combined with Synomics Pharma’s robust quality system, responsive team, and state-of-the-art bioanalysis techniques, creates an exceptional resource for outsourcing phase I clinical trials,” said Daryl Paulson, Ph.D., Chief Executive Officer of BioScience Laboratories. “Synomics Pharma’s comprehensive quality management system reduces regulatory risk,” said John Pirro, Vice President and Chief Operating Officer of Synomics Pharma. “Our active involvement with the Bioanalytical Quality Standards Initiative (BQSI) for the implementation of ICH Q10 for clinical trials demonstrates our commitment to consistency and quality in clinical bioanalysis. The alliance between Synomics Pharma and BioScience Laboratories produces a versatile topical clinical phase 1 study service offering that will be highly beneficial to the industry.”
A white paper from Synomics Pharma, titled “BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials”, describes the BQSI, an initiative born out of the industry-wide recognition that neither the US FDA or EMEA regulation nor ICH harmonized guidelines address laboratory analysis in support of clinical trials.